Infant, NewbornPhase 2NCT00334737
Darbepoetin Administration to Preterm Infants
A Phase 2 study testing Darbepoetin Alfa Injection and erythropoietin alfa injection in people with Infant, Newborn, run by University of New Mexico at 3 sites in United States.
Trial summary
Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Read more about this study
- Who is it for?
- Ages 1 hour to 49 hours
- Conditions the study is for
- Infant, Newborn
- What is being tested?
- Darbepoetin Alfa Injection and erythropoietin alfa injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2006to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 49 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 500-1250 grams birth weight
- less than or equal to 32 weeks gestation
- less than 2 days of age
Who cannot join
- severe hemorrhagic disease
- severe hemolytic disease
- DIC
- seizures
- hypertension
- thromboses
- receiving erythropoietin
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado
Denver, Colorado, 80218
McKay-Dee Hospital
Ogden, Utah, 84403
LDS Hospital
Salt Lake City, Utah, 84103
About this study
Official title: A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants
Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is successful in treating the anemia of prematurity. A slightly modified, long-acting version of rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in increasing hematocrit (red blood cell levels) in adults. In addition to its red cell stimulating properties, recent evidence has shown that rHuEpo is protective in the developing or injured brain. We have designed a randomized, masked, placebo-controlled study to determine the safety and short and long term efficacy of darbepoetin. At this time, darbepoetin has been studied primarily in adults and pediatric patients, but there is evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well. It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight will result in increased reticulocyte counts and decreased transfusions compared to placebo; and 2. The administration of darbepoetin will be associated with an increased mental developmental index at 18-22 months compared to placebo.
Read the detailed description
A novel erythropoiesis stimulating protein, Darbepoetin alfa (Darbepoetin) has been developed by Amgen Inc. and has been shown to be effective in increasing hematocrit using once weekly or once every other week dosing in adults with anemia due to end stage renal disease or cancer. However, it is presently being evaluated for use in children with hyporegenerative anemias, and has not yet been evaluated for use in infants with anemia of prematurity. Preterm infants respond to human recombinant erythropoietin (Epo) by increasing reticulocytes, yet the multiple subcutaneous doses diminish its routine use in the NICU. With the possibility of once a week or once every other week dosing, the use of Darbepoetin in this population appears promising. While it is likely that the use of red cell growth factors such as rHuEpo or darbepoetin will not eliminate the need for all erythrocyte transfusions in all infants, it is reasonable to postulate that the use of darbepoetin will eliminate the need for transfusion in some preterm infants, and reduce the need in others. European studies evaluating rHuEpo in preterm infants have successfully decreased donor exposure to 1 per patient. Our goal is to achieve similar success, which we define as a donor exposure of ≤1 donor per infant in clinical practice. This can be achieved through the use of red cell growth factors, judicious use of blood work for monitoring, and stringent transfusion guidelines. By decreasing total transfusions to <4 per infant, we can achieve this goal of ≤1 donor exposure per infant.
There will remain a population of extremely small, extremely ill infants in whom phlebotomy losses exceed the capacity to increase red cell mass through the use of Epo. Some investigators believe a combination of single donor erythrocyte transfusions and recombinant erythropoietin can serve to maintain an adequate circulating erythrocyte volume. A reasonable algorithm can be developed to assist in these determinations only through continued research. Continued critical evaluation of transfusion criteria, outcomes, new technologies limiting phlebotomy loss, and novel biologic and pharmacologic treatments can only serve to improve the care of ELBW infants who are highest risk for repeated transfusions. Our research aim is to study the safety and efficacy of darbepoetin in preterm infants in order to improve the outcomes of preterm infants by significantly decreasing the number of transfusions. Moreover, improving neurodevelopmental outcomes for preterm infants continues to be a goal for neonatal care providers that might begin to be approached through darbepoetin therapy. This study differs from previous erythropoietin studies in the following ways:
- Darbepoetin will be compared to placebo and to rHuEpo, allowing two thirds of the patients to receive some form of red cell growth factor, and allowing SC dosing to occur once a week in the darbepoetin recipients compared with the usual three times a week SC dosing in the rHuEpo recipients (those in the placebo group will not receive sham injections)
- Dosing will begin 1-2 days earlier on average than in any previously published study
- Transfusion guidelines are the most rigorous applied to date, and will be used at sites that are all at altitudes > 4,000 feet
- A target Epo concentration of >500 mU/mL in the treatment group is proposed in order to evaluate neurodevelopmental differences between groups, and the study is powered to determine a difference between treatment groups and placebo
- Conditions
- Infant, Newborn
- Being tested
- Darbepoetin Alfa Injection, erythropoietin alfa injection, sham injection
- Keywords
- erythropoietin, darbepoetin, transfusions, neonates, outcomes, neurodevelopment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin Alfa InjectionDrug
Also called aranesp, Darbe
darbepoetin alfa injection 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks
erythropoietin alfa injectionDrug
Also called procrit, epoetin alfa
Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation
sham injectionDrug
Also called placebo
sham injection other names: not applicable
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa injection | Experimental | Darbepoetin alfa 10 mics/kg/week subcutaneous injection x 10 weeks or until 35 completed weeks Drug: Darbepoetin alfa Other names: Aranesp Darbe SC injection Receives: Drug: Darbepoetin Alfa Injection |
| erythropoietin alfa injection | Active comparator | Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks Drug: erythropoietin other names: epogen Epo SC injection Receives: Drug: erythropoietin alfa injection |
| placebo/control | Placebo comparator | Sham injection Receives: Drug: sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Transfusions During Hospitalization
Measured: From birth to 36 weeks gestational age
Composite Cognitive Score at 18-22 Months Corrected Age
Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.
Measured: 18-22 months
Secondary outcomes (7)
Hematocrit
Measured: From birth to 36 weeks gestational age
Reticulocyte Count
absolute retic count measured at the end of study
Measured: at day 60 of study
Volume of Transfusions
Measured: From birth to 36 weeks gestational age
Epo Concentrations
Measured: peak from birth to 36 weeks gestational age
Object Permanence Scores at 18-22 Months
Scores are 0-3, with 3 being the best score.
Measured: 18-22 months
Overall Neurodevelopmental Impairment at 18-22 Months (Visual Impairment, Hearing Impariment, Cerebral Palsy, or Cognitive Score <85/<70 (NDI/Moderate NDI)
Measured: 18-22 months
Incidence of Retinopathy of Prematurity Stage 3 or Greater
Measured: From birth to 36 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, University of Colorado, Denver, Intermountain Health Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Robin K Ohls, MD, Principal investigator, University of New MexicoRobert D Christensen, MD, Principal investigator, McKay-Dee Hospital, Ogden, UtahSusan Wiedmeier, MD, Principal investigator, LDS Hospital, Salt Lake City, UtahAdam Rosenberg, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334737
- Sponsor's protocol ID
- 06-139
- Status last verified
- Jan 2019
- First submitted
- 7 Jun 2006
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Will enter in DASH if appropriate
Publications
Warwood TL, Ohls RK, Wiedmeier SE, Lambert DK, Jones C, Scoffield SH, Neeraj G, Veng-Pedersen P, Christensen RD. Single-dose darbepoetin administration to anemic preterm neonates. J Perinatol. 2005 Nov;25(11):725-30. doi: 10.1038/sj.jp.7211387.
PubMed 16151471Ohls RK, Dai A. Long-acting erythropoietin: clinical studies and potential uses in neonates. Clin Perinatol. 2004 Mar;31(1):77-89. doi: 10.1016/j.clp.2004.03.006.
PubMed 15183658Warwood TL, Ohls RK, Lambert DK, Jones C, Scoffield SH, Gupta N, Veng-Pedersen P, Christensen RD. Intravenous administration of darbepoetin to NICU patients. J Perinatol. 2006 May;26(5):296-300. doi: 10.1038/sj.jp.7211498.
PubMed 16554846Ohls RK, Ehrenkranz RA, Das A, Dusick AM, Yolton K, Romano E, Delaney-Black V, Papile LA, Simon NP, Steichen JJ, Lee KG; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome and growth at 18 to 22 months' corrected age in extremely low birth weight infants treated with early erythropoietin and iron. Pediatrics. 2004 Nov;114(5):1287-91. doi: 10.1542/peds.2003-1129-L.
PubMed 15520109Lowe JR, Rieger RE, Moss NC, Yeo RA, Winter S, Patel S, Phillips J, Campbell R, Baker S, Gonzales S, Ohls RK. Impact of Erythropoiesis-Stimulating Agents on Behavioral Measures in Children Born Preterm. J Pediatr. 2017 May;184:75-80.e1. doi: 10.1016/j.jpeds.2017.01.020. Epub 2017 Feb 6.
PubMed 28185625Ohls RK, Cannon DC, Phillips J, Caprihan A, Patel S, Winter S, Steffen M, Yeo RA, Campbell R, Wiedmeier S, Baker S, Gonzales S, Lowe J. Preschool Assessment of Preterm Infants Treated With Darbepoetin and Erythropoietin. Pediatrics. 2016 Mar;137(3):e20153859. doi: 10.1542/peds.2015-3859. Epub 2016 Feb 15.
PubMed 26908704
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants
- ClinicalTrials.gov ID
- NCT00334737
- Acronym / sponsor ID
- 06-139
- Conditions
- Infant, Newborn
- Keywords
- erythropoietin, darbepoetin, transfusions, neonates, outcomes, neurodevelopment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, University of Colorado, Denver, Intermountain Health Care, Inc.
- Study start
- Jun 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Jun 2006 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is successful in treating the anemia of prematurity. A slightly modified, long-acting version of rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in increasing hematocrit (red blood cell levels) in adults. In addition to its red cell stimulating properties, recent evidence has shown that rHuEpo is protective in the developing or injured brain. We have designed a randomized, masked, placebo-controlled study to determine the safety and short and long term efficacy of darbepoetin. At this time, darbepoetin has been studied primarily in adults and pediatric patients, but there is evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well. It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight will result in increased reticulocyte counts and decreased transfusions compared to placebo; and 2. The administration of darbepoetin will be associated with an increased mental developmental index at 18-22 months compared to placebo.
Detailed description
A novel erythropoiesis stimulating protein, Darbepoetin alfa (Darbepoetin) has been developed by Amgen Inc. and has been shown to be effective in increasing hematocrit using once weekly or once every other week dosing in adults with anemia due to end stage renal disease or cancer. However, it is presently being evaluated for use in children with hyporegenerative anemias, and has not yet been evaluated for use in infants with anemia of prematurity. Preterm infants respond to human recombinant erythropoietin (Epo) by increasing reticulocytes, yet the multiple subcutaneous doses diminish its routine use in the NICU. With the possibility of once a week or once every other week dosing, the use of Darbepoetin in this population appears promising. While it is likely that the use of red cell growth factors such as rHuEpo or darbepoetin will not eliminate the need for all erythrocyte transfusions in all infants, it is reasonable to postulate that the use of darbepoetin will eliminate the need for transfusion in some preterm infants, and reduce the need in others. European studies evaluating rHuEpo in preterm infants have successfully decreased donor exposure to 1 per patient. Our goal is to achieve similar success, which we define as a donor exposure of ≤1 donor per infant in clinical practice. This can be achieved through the use of red cell growth factors, judicious use of blood work for monitoring, and stringent transfusion guidelines. By decreasing total transfusions to <4 per infant, we can achieve this goal of ≤1 donor exposure per infant.
There will remain a population of extremely small, extremely ill infants in whom phlebotomy losses exceed the capacity to increase red cell mass through the use of Epo. Some investigators believe a combination of single donor erythrocyte transfusions and recombinant erythropoietin can serve to maintain an adequate circulating erythrocyte volume. A reasonable algorithm can be developed to assist in these determinations only through continued research. Continued critical evaluation of transfusion criteria, outcomes, new technologies limiting phlebotomy loss, and novel biologic and pharmacologic treatments can only serve to improve the care of ELBW infants who are highest risk for repeated transfusions. Our research aim is to study the safety and efficacy of darbepoetin in preterm infants in order to improve the outcomes of preterm infants by significantly decreasing the number of transfusions. Moreover, improving neurodevelopmental outcomes for preterm infants continues to be a goal for neonatal care providers that might begin to be approached through darbepoetin therapy. This study differs from previous erythropoietin studies in the following ways:
- Darbepoetin will be compared to placebo and to rHuEpo, allowing two thirds of the patients to receive some form of red cell growth factor, and allowing SC dosing to occur once a week in the darbepoetin recipients compared with the usual three times a week SC dosing in the rHuEpo recipients (those in the placebo group will not receive sham injections)
- Dosing will begin 1-2 days earlier on average than in any previously published study
- Transfusion guidelines are the most rigorous applied to date, and will be used at sites that are all at altitudes > 4,000 feet
- A target Epo concentration of >500 mU/mL in the treatment group is proposed in order to evaluate neurodevelopmental differences between groups, and the study is powered to determine a difference between treatment groups and placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa injection | Experimental | Drug: Darbepoetin Alfa InjectionDarbepoetin alfa 10 mics/kg/week subcutaneous injection x 10 weeks or until 35 completed weeks Drug: Darbepoetin alfa Other names: Aranesp Darbe SC injection |
| erythropoietin alfa injection | Active comparator | Drug: erythropoietin alfa injectionEpo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks Drug: erythropoietin other names: epogen Epo SC injection |
| placebo/control | Placebo comparator | Drug: sham injectionSham injection |
Who may qualify
- Ages
- 1 hour to 49 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 500-1250 grams birth weight
- less than or equal to 32 weeks gestation
- less than 2 days of age
Key exclusion criteria (7 listed)
- severe hemorrhagic disease
- severe hemolytic disease
- DIC
- seizures
- hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin Alfa InjectionAlso: aranesp, Darbedarbepoetin alfa injection 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks | Drug | Darbepoetin alfa injection |
| erythropoietin alfa injectionAlso: procrit, epoetin alfaEpo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation | Drug | erythropoietin alfa injection |
| sham injectionAlso: placebosham injection other names: not applicable | Drug | placebo/control |
Primary outcome
Number of Transfusions During Hospitalization
Time frame: From birth to 36 weeks gestational age
Composite Cognitive Score at 18-22 Months Corrected Age
Time frame: 18-22 months
Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.
7 secondary outcomes
Hematocrit
Time frame: From birth to 36 weeks gestational age
Reticulocyte Count
Time frame: at day 60 of study
Volume of Transfusions
Time frame: From birth to 36 weeks gestational age
Epo Concentrations
Time frame: peak from birth to 36 weeks gestational age
Object Permanence Scores at 18-22 Months
Time frame: 18-22 months
Overall Neurodevelopmental Impairment at 18-22 Months (Visual Impairment, Hearing Impariment, Cerebral Palsy, or Cognitive Score <85/<70 (NDI/Moderate NDI)
Time frame: 18-22 months
Incidence of Retinopathy of Prematurity Stage 3 or Greater
Time frame: From birth to 36 weeks gestational age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16151471Warwood TL, Ohls RK, Wiedmeier SE, Lambert DK, Jones C, Scoffield SH, Neeraj G, Veng-Pedersen P, Christensen RD. Single-dose darbepoetin administration to anemic preterm neonates. J Perinatol. 2005 Nov;25(11):725-30. doi: 10.1038/sj.jp.7211387.
- Background: PubMed 15183658Ohls RK, Dai A. Long-acting erythropoietin: clinical studies and potential uses in neonates. Clin Perinatol. 2004 Mar;31(1):77-89. doi: 10.1016/j.clp.2004.03.006.
- Background: PubMed 16554846Warwood TL, Ohls RK, Lambert DK, Jones C, Scoffield SH, Gupta N, Veng-Pedersen P, Christensen RD. Intravenous administration of darbepoetin to NICU patients. J Perinatol. 2006 May;26(5):296-300. doi: 10.1038/sj.jp.7211498.
- Background: PubMed 15520109Ohls RK, Ehrenkranz RA, Das A, Dusick AM, Yolton K, Romano E, Delaney-Black V, Papile LA, Simon NP, Steichen JJ, Lee KG; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome and growth at 18 to 22 months' corrected age in extremely low birth weight infants treated with early erythropoietin and iron. Pediatrics. 2004 Nov;114(5):1287-91. doi: 10.1542/peds.2003-1129-L.
- Derived from this study: PubMed 28185625Lowe JR, Rieger RE, Moss NC, Yeo RA, Winter S, Patel S, Phillips J, Campbell R, Baker S, Gonzales S, Ohls RK. Impact of Erythropoiesis-Stimulating Agents on Behavioral Measures in Children Born Preterm. J Pediatr. 2017 May;184:75-80.e1. doi: 10.1016/j.jpeds.2017.01.020. Epub 2017 Feb 6.
- Derived from this study: PubMed 26908704Ohls RK, Cannon DC, Phillips J, Caprihan A, Patel S, Winter S, Steffen M, Yeo RA, Campbell R, Wiedmeier S, Baker S, Gonzales S, Lowe J. Preschool Assessment of Preterm Infants Treated With Darbepoetin and Erythropoietin. Pediatrics. 2016 Mar;137(3):e20153859. doi: 10.1542/peds.2015-3859. Epub 2016 Feb 15.
- Individual participant dataSharing planned: Undecided. Will enter in DASH if appropriate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin K Ohls, MD principal investigator
University of New Mexico
Robert D Christensen, MD principal investigator
McKay-Dee Hospital, Ogden, Utah
Susan Wiedmeier, MD principal investigator
LDS Hospital, Salt Lake City, Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darbepoetin Alfa Injection and erythropoietin alfa injection in people with Infant, Newborn, run by University of New Mexico at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Transfusions During Hospitalization (time frame: From birth to 36 weeks gestational age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00334737, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.